Prostate Nodule
Conditions
Keywords
3T MRI, 7T MRI
Brief summary
A comparison of 3 Tesla MRI to 7 Tesla MRI for Evaluation of Prostate Suspicious Lesions. Assess the added diagnostic value of ultra-high-field (7T) MRI over the current clinical standard (3T MRI) in detecting and characterizing suspicious prostate lesions. Evaluate whether dynamic deuterated glucose-enhanced imaging at 7T can offer improved contrast without the use of gadolinium-based agents.
Detailed description
Multiparametric MRI (mpMRI) at 3 Tesla is the current standard of care for the evaluation of prostate cancer, but its diagnostic accuracy is limited by false positives, particularly in the transition zone. This leads to unnecessary biopsies and potential overtreatment. Ultra-high-field 7 Tesla (7T) MRI offers higher signal-to-noise ratio, superior spatial and spectral resolution, and the ability to implement advanced imaging techniques without the need for endorectal coils. In addition, dynamic glucose-enhanced MRI at 7T provides a promising alternative to gadolinium-based contrast agents, which are associated with safety concerns.
Interventions
DIAGNOSTIC_TEST3T and 7T MRI scans
Imaging protocols will include multiparametric sequences at both field strengths, with the addition of high-resolution anatomical and optional dynamic glucose-enhanced imaging at 7T.
Sponsors
Assaf-Harofeh Medical Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 75 Years
Healthy volunteers
Yes
Inclusion criteria
* male patients referred for clinical 3T prostate MRI at Shamir Medical Center * male patients who consent to undergo an additional 7T scan at the Weizmann Institute.
Exclusion criteria
* Contraindications to MRI (e.g., non-compatible implants, pacemakers, severe claustrophobia) * diabetes mellitus * glucose intolerance * hyperglycemia * hyperlactatemia * chronic kidney disease (GFR \<45 mL/min/1.73 m2).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| ROC analysis of diagnostic performance: 3T versus 7T MRI | Assessed at the time of MRI acquisition during the study imaging visit. | ROC analysis (Receiver Operating Characteristic analysis) - A statistical method used to evaluate and compare diagnostic accuracy. It examines how well a test distinguishes between diseased and non-diseased cases across different thresholds. |
| Sensitivity and Specificity of diagnostic performance: 3T versus 7T MRI | Assessed at the time of MRI acquisition during the study imaging visit. | Sensitivity - The ability of the MRI to correctly identify patients who truly have disease (true positive rate). High sensitivity means fewer missed cases. Specificity - The ability of the MRI to correctly identify patients who do not have disease (true negative rate). High specificity means fewer false alarms or false positives. |
| Lesion conspicuity of diagnostic performance: 3T versus 7T MRI | Assessed at the time of MRI acquisition during the study imaging visit. | How clearly and visibly an abnormal lesion can be seen on MRI images compared with surrounding tissue. Higher conspicuity generally makes lesions easier to detect and characterize. |
| PI-RADS classification - The Prostate Imaging Reporting and Data System: 3T versus 7T MRI | Assessed at the time of MRI acquisition during the study imaging visit. | a standardized scoring system used in prostate MRI to estimate the likelihood of clinically significant prostate cancer. Scores range from 1 (very low likelihood) to 5 (very high likelihood). |
| Quantitative imaging metrics of diagnostic performance: 3T versus 7T MRI | Assessed at the time of MRI acquisition during the study imaging visit. | Numerical measurements derived from MRI images, such as lesion size, signal intensity, contrast ratios, diffusion values (e.g., ADC), or texture features, used to objectively compare imaging performance. |
Countries
Israel
Contacts
CONTACTShai Efrati, MD
PRINCIPAL_INVESTIGATORShai Efrati
Asaf-Harofhe MC
Outcome results
None listed